Responsibilities will include, but not be limited to :
Primary technical and management leadership resource for people, processes, systems, and equipment for Manufacturing Engineering at Elixir.
Requires detailed technical knowledge of processes and systems. Must be able to optimize existing processes and systems, and design for future requirements
- Manage internal and external (contract and consultant) resources to deliver Manufacturing Engineering initiatives on-time and on-budget
- Develop Manufacturing Engineering projects to improve quality, capacity, and cost. Lead cross-functional stakeholder groups for projects.
Analyze benefits vs investment for initiatives. Propose projects to executive management. Manage projects and resources from initiation to implementation
- Build and manage team with internal and external resources to appropriately address Manufacturing Engineering requirements
- Resolve manufacturing equipment issues
- Work with the R&D team to develop and optimize manufacturing processes
- Develop, communicate, and revisit performance expectations with Manufacturing Engineering resources
- Manage internal and external resources to optimize and maintain facilities
- Maintain compliance with FDA and ISO guidelines for medical device development and manufacturing
- Maintain compliance with all document and procedure training requirements
Experience
- BS in Engineering discipline, Master's degree a plus
- Minimum 12 years combined experience in Manufacturing Engineering and ME management in medical device industry
- Knowledge of Statistics, Data Analysis, ISO / ASTM test methods and Geometric Tolerance Analysis
- Experience developing and managing budgets with strong financial, contract management and purchasing skills
- Solid operational management experience together with the ability to work in a collaborative environment
- Excellent communication, both verbal and written and people skills
- Advanced Excel and solid Word skills. SolidWorks is a plus
- Experience with ERP system such as QAD, Oracle, SAP or similar is a plus
- Experience with electronic Quality Management Systems such as Arena is a plus
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